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| Sponsor: | MedImmune LLC |
|---|---|
| Information provided by: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00767416 |
Purpose
The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10:5 FFU when administered to healthy RSV seronegative children 5 to <24 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Biological: MEDI-559 Other: Placebo |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-559, a Live Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus in Healthy 1 to <24 Month-Old Children |
| Estimated Enrollment: | 320 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
MEDI-559
|
Biological: MEDI-559
Cohort 1 (5 to <24 months): N=80 MEDI-559 at 105 FFU at 0, 2, and 4 months N=80 Placebo at 0, 2, and 4 months
|
|
2: Experimental
MEDI-559
|
Biological: MEDI-559
Cohort 2 (1 to <3 months): N=80 MEDI-559 at 105 FFU at 0, 2, and 4 months N=80 Placebo at 0, 2, and 4 months
|
|
Placebo: Placebo Comparator
Placebo
|
Other: Placebo
frozen preparation filled into 0.5 ml; each 0.2 ml dose contains sucrose phosphate buffer.
|
The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10:5 FFU when administered to healthy RSV seronegative children 5 to <24 months of age and to healthy infants 1 to <3 months of age regardless of baseline serostatus.
Eligibility| Ages Eligible for Study: | 5 Months to 23 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michele Jordan | 301-398-4167 | |
| Contact: Mark Eickhoff | 301-398-5038 |
Show 70 Study Locations| Study Director: | Joseph Sliman, M.D. | MedImmune LLC |
More Information
| Responsible Party: | MedImmune LLC ( Joseph Sliman, M.D. ) |
| Study ID Numbers: | MI-CP147 |
| Study First Received: | October 3, 2008 |
| Last Updated: | December 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00767416 History of Changes |
| Health Authority: | United States: Food and Drug Administration |